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Shimadzu Corp.
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SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC is an FDA 510(k)-cleared medical device (K011141) manufactured by Shimadzu Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 2, 2001. Regulation: 8.